Palbociclib Pfizer

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HomeAboutMode of actionEfficacyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)Real World EvidenceP-REALITY study designP-REALITY patients characteristicsP-REALITY real-world progression-free survivalP-REALITY overall survivalP-REALITY strengthsSafetyImportant Safety InformationSafetySafety overviewPooled ARsPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresPalbociclib long-term safetyGI and liver toxicitiesEffect of Palbociclib on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyDosingRecommended dosing scheduleRecommended dose modifications for AEsOne scheduled monitoring provisionMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Dose reduction effect on efficacy

This was an intra-arm comparison. When evaluating the data, note this analysis was not powered to make comparisons within treatment arms and patient numbers were small.

Adapted from Diéras V, et al. 2019.1
Data cut-off date: February 26, 2016. *Patients with PFS time ≤9 months were excluded.

  • Among patients with all-causality AEs associated with dose reduction in the Palbociclib Pfizer + letrozole arm, 67.5% had a dose reduction associated with neutropenia (24.3% of patients in the Palbociclib Pfizer + letrozole arm vs 0.5% of patients in the placebo + letrozole arm)1
  • 14.4% had a dose reduction associated with decreased neutrophil count (5.2% in the Palbociclib Pfizer arm vs 0% in the placebo arm)1
  • 3.8% had a dose reduction associated with febrile neutropenia (1.4% in the Palbociclib Pfizer arm vs 0% in the placebo arm)1
AE = adverse event; GI = gastrointestinal; LET = letrozole; mo = months; n = number of patients; PFS = progression-free survival; QTc = QT interval corrected for heart rate.References:Diéras V, et al. Oncologist. 2019;24(12):1514-1525.
Selected safety features

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